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Behavioral Intervention

Dialectical Behavior Therapy for Bipolar Disorder (DB2 Trial)

N/A
Recruiting
Led By Benjamin I Goldstein, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of study completion (five years)
Awards & highlights

Summary

This trial is studying the use of additional help (booster sessions) for youth with bipolar disorder who have already completed 1 year of Dialectical Behavioral Therapy. Sessions and skills coaching are offered depending on the participant's preference.

Who is the study for?
This trial is for young people aged 14 to nearly 26 who have bipolar disorder or are at risk due to family history. They must have finished a year of DBT in prior studies, be under care by a CAMH psychiatrist, and if they have BD-I, be on mood stabilizers. Participants need to speak English and consent to join.
What is being tested?
The study tests 'booster' sessions of Dialectical Behavior Therapy (DBT) tailored for youth with/at risk for bipolar disorder. It includes individual therapy, skills training based on preference, and optional phone coaching. There's no comparison treatment; the focus is on these extra DBT sessions.
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, typical side effects associated with drugs aren't expected. However, discussing emotional topics can sometimes cause temporary distress or discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of study completion (five years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of study completion (five years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy
Number of unscheduled/expedited DBT sessions that are required measured using the Therapy
Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form
Secondary study objectives
Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Youth with and/or at familial risk for bipolar disorderExperimental Treatment1 Intervention
120 youth aged 14 to 26 with bipolar disorder (type I, type II, not otherwise specified/NOS via KSADS-PL or SCID-5-RV) OR at high-risk for bipolar disorder (parent or sibling with bipolar disorder type I or II via KSADS-PL or SCID-5-RV) will be enrolled in the dialectical behavioral therapy booster session intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dialectical behavioral therapy
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,216 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,399 Patients Enrolled for Bipolar Disorder
Benjamin I Goldstein, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
176 Total Patients Enrolled
5 Trials studying Bipolar Disorder
176 Patients Enrolled for Bipolar Disorder

Media Library

Dialectical Behavioral Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05627492 — N/A
Bipolar Disorder Research Study Groups: Youth with and/or at familial risk for bipolar disorder
Bipolar Disorder Clinical Trial 2023: Dialectical Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05627492 — N/A
Dialectical Behavioral Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627492 — N/A
~80 spots leftby Nov 2028
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